BioLife Plasma Services, a subsidiary of Takeda Pharmaceutical Company Ltd., is an industry leader in the collection of high-quality plasma that is processed into life-saving plasma-based therapies.. This position is currently classified as Hybrid in accordance with Takeda’s Hybrid and Remote Work policy.. Foster collaboration across HR, operations, DD&T, forecasting, and leadership teams to enhance workforce efficiencies and address organizational priorities.. Integrate workforce strategies seamlessly into BioLife Plasma Center operations to align with organizational objectives.. Partner closely with HR, operations, DD&T, forecasting, and BioLife leadership to ensure the alignment of shared workforce processes.
The Analyst I in Quality Control Operations will play a critical role in executing assays, generating accurate and reliable data, and supporting the general operations of the laboratory to ensure the quality and compliance of our products from development through to commercialization.. Adhere to internal standards, policies, and SOPs, as well as regulatory and industry standards (e.g., GMP, GLP, ICH guidelines) to maintain the highest levels of quality and compliance.. Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.. 0 to 2 years of experience in a GMP/GLP regulated laboratory environment, with exposure to pharmaceutical or biotechnology industries preferred.. Basic awareness of regulatory guidelines relevant to pharmaceutical QC (GMP, GLP, ICH) is desirable.
Overview Resource Label Group, LLC is a leading full-service provider of label and packaging solutions with a diverse product offering which includes pressure sensitive labels, shrink sleeves, RFID/NFC technology, sustainable product solutions, scent activation technology, pharmaceutical packaging and fulfillment services.. Resource Label provides products and services for the food, beverage, chemical, household products, personal care, nutraceutical, pharmaceutical, medical device, and technology industries.. We are currently recruiting a Human Resources Generalist to join our Oxford Graphics team!. Administer payroll by verifying hours worked in accordance with state laws, experience utilizing ADP Workforce Now is preferred.. Proficiency in HRIS systems (preferably ADP Workforce Now) and tools for efficient data management and analysis.
Tasks may also include supporting Foreign Military Sales.. Support engineering technical and technical management processes associated with version/configuration control, to include: a) Requirements definition and analysis; b) Architecture design, implementation, integration, verification, validation, transition, decision analysis, technical planning, technical assessment; c) Requirements management, risk management, configuration management, technical data management, and interface management.. Complete and support requirements definition and analysis, architecture design, implementation, integration, verification and validation, transition, decision analysis, requirements management, risk management, interface management, and configuration management.. Participate in integrated logistics support efforts, provisioning and source coding, maintenance data collection, technical order management, configuration management, evaluation of quality deficiency reports, and/or identification of alternate sources of supply for diminishing manufacturing/materiel sources preferred.. Experience with network architectures, embedded systems and application deployment across a variety of systems and hardware, to include cloud deployment and virtualization.
Senior Director, Supply Chain Operations.. Join to apply for the Senior Director, Supply Chain Operations role at Boston Medical Center (BMC).. Under the supervision of the Vice President Supply Chain Operations, this position is responsible for oversight of various operational aspects of the health system supply chain to include procurement, warehousing, distribution, inventory control, vendor management, freight, safety, product recalls, and budgetary management. Association for Supply Chain Management CPIM, CSCP, CLTD; Institute for Supply Management CPSM; or similar certification preferred.. Get notified about new Director Supply Chain Operations jobs in Boston, MA.
Support CMC Analytical Development in a QC aspect by review and approval of applicable documents in support of activities such as method development, transfer, characterization, comparability investigations, analytical test method qualification plans/protocols and reports. Perform data review of trending for in-process testing, release, and stability and identify data trends, to ensure compliance with regulatory filings and ICH or other global health authority guidance documents, as applicable. QC support in the generation, quality, and compliance review of bioanalytical data from preclinical and clinical projects for proprietary compounds and in some cases support for sample analysis projects. In-depth technical and regulatory understanding of GMP biologics manufacturing and testing including applicable international regulations/standards (GMP and ICH guidelines) in all phases of product development and commercialization. Experience managing third party assay laboratories, collaborations, and relevant bioanalytical vendors preferred.
Wood Mackenzie is the global data and analytics business for the renewables, energy, and natural resources industries. Depending on the size of the project that you are staffed on, you may have Consultants on the team over which you may play a vital role in mentoring and performing QA/QC on the work that they perform. Provide deep analysis of quantitative and qualitative data and synthesize results into meaningful conclusions to help our clients make strategic procurement and capital project decisions.. Support the bidding processes for large capital project contracts and strategic supply chain initiatives, including performing pricing analysis, coordinating bidder correspondence, designing and orchestrating bidder negotiations and implementing contracts.. Use WoodMac Energy Intelligence Platform software tools to analyze spend, build custom cost models, forecast escalation, manage eSourcing bid events and support many of our other consulting solutions.
Supply chain Manager CDI LinkedIn. · Familiarity with supply chain management tools like WMS, TMS, OMS, ERP, or experience with these software systems is a plus.. An APICS certification (CPIM/CSCP) is a definite advantage.. · Project Management: Supporting project management and selecting specialized information systems (APS, TMS, WMS, OMS, etc.). You’ll leverage our methodologies, tools (IMCM repository, serious games, and supply chain classics), and participate in business development, including identifying customer needs, drafting proposals, pre-sales activities, and participating in project qualification and defense.
The QC Analyst II is responsible for conducting routine and non-routine analyses of raw materials, in-process materials and finished products in accordance with cGMP guidelines.. Test and analyze samples in a timely manner in support of project plans in accordance with cGMP guidelines.. Review data for compliance against specifications and GMP regulations.. 2-5 years' experience as a QC analyst/chemist in a GMP environment. Experience and familiarity with analytical testing equipment and methodology including HPLC, Karl Fischer, Spectrophotometry (UV/VIS), and LCMS
Perform engineering runs and execute on-floor testing/troubleshooting using biomanufacturing instruments such as Spectro-photometers, Optical Density-meters, conductivity meters, pumps and filtration systems, chromatography, tangential flow filtration. Requires a Master’s degree in Biomedical Engineering, Biochemical Engineering, Biotechnology or related field and eight (8) years of experience in the position offered or as a Technical Development Engineer, Biochemical Engineer, Scientist, Specialist or related position.. Chromatography, Tangential flow filtration (TFF) system, fill finish operations, columns, column packing, spectrophotometers, Optical density meters, conductivity meters, pumps, valves, and filtration systems;. Change management and deviation support using quality management systems and cGMP guidelines using VEEVA;. A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
We are seeking a Technical Sales Manager with exceptional intellectual capabilities and a passion for problem-solving.. This role is not about hard selling; it's about being a knowledgeable evangelist for our innovative solutions in the world of industrial automation.. 5+ years of experience in B2B sales, preferably in the software or industrial automation sectors.. Sales experience in a startup environment, ideally at a growing stage, demonstrating an ability to adapt and thrive in dynamic settings.. Previous experience as a Product Owner or in an engineering role is highly desirable, providing a deep understanding of technical product aspects and customer needs.
May design and develop robust and scalable formulations for small molecules and biologics for early-stage clinical trials.. Provides complex to specialized analysis, interpretation and counsel to clients, staff, management, and functional leaders regarding chemistry/biochemistry policies, programs, and practices; involves broad operations and leading implementation and change.. Provide routine and non-routine analysis using instruments such as HPLC, GC, LC-MS, and FTIR, among others.. Design and develop robust and scalable formulations for small molecules and biologics for early-stage clinical trials.. Ensure all activities adhere to SOP's, regulatory guidelines, GLP and GMP standards.
Quality Systems Manager (QSM). · Evaluates processes, develops action plans, and coordinates the strategic implementation of quality system processes and corrective actions at the plasma donor center.. · Oversees product and biohazard waste shipments: Ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and documentation and authorizes final shipment.. · Ensures that Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented.. Ability to travel when needed for meetings, events, and occasional support of other centers.
GMP Quality Assurance Specialist – Batch Record & Lot Release GMP Quality Assurance Specialist – Batch Record & Lot Release Direct message the job poster from Mix Talent. Talent Acquisition | Hunter of Purple Squirrels and Magical Unicorns | Top 25% of LinkedIn Recruiters 2023 & 2024 Mix has partnered with an innovative and industry-leading company to find a talented Quality Assurance Specialist!. This position would be ideal for professionals with experience in life sciences, biotech, pharmaceuticals, or regulated manufacturing and hands-on expertise with Good Documentation Practice , cGMP , batch records , vendor audits , and FDA/regulatory compliance.. Industries Biotechnology Research, Manufacturing, and Pharmaceutical Manufacturing. QA Specialist II, Validation, Contractor Senior Associate Quality Assurance Operations Quality Assurance Specialist, Batch Records Raw Materials Marlborough, MA $127,900.00-$243,000.00 1 week ago
The ideal candidate will work cross-functionally with leadership, IT, and business stakeholders to align technology solutions with organizational goals.. 10+ years of experience in business systems or IT management roles, including 5+ years in a leadership position.. Proven experience with ERP and other enterprise platforms (e.g., SAP, Oracle, NetSuite, Salesforce).. Strong knowledge of business process mapping, systems integration, and data governance.. Lean Six Sigma, PMP, or similar certifications.
Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets.. The QC Manager will manage stability data from CMO/CTL, manage change and investigations, support ongoing regulatory filings.. Perform trend analysis of testing data including stability trends, lot release and assay control. Well versed in various analytical and bioanalytical techniques (e.g., ELISAs, spectroscopy, HPLC/UPLC, electrophoresis, compendial and other methods for biopharmaceuticals). Experience with Veeva eDMS, LIMS software, Statistical software, Smartsheets preferred
We are seeking an innovative and highly motivated Principal Enterprise Architect, GMP Systems who will play a critical role in the launch and ramp-up of a state-of-the-art multi-product cell therapy manufacturing facility that will be utilized to manufacture autologous and allogeneic cell therapy products.. Partner with the IDMO Business to develop and execute against an IT roadmap and deliver on the IT infrastructure needed to manufacture autologous and allogeneic cell therapy products. Drive the selection, implementation, and support of various business applications, including ERP, MES, LIMS, QMS, etc.. Experience Implementing Manufacturing, Quality, and Supply Chain applications, including ERP, MES, LIMS, QMS, etc.. Berkeley Heights, NJ / Princeton, NJ Principal Engineer, Modern Workplace Technologies
Supply Chain Operations Specialist IV CEVA Logistics provides global supply chain solutions to connect people, products, and providers all around the world.. That is why CEVA Logistics offers a dynamic and exceptional work environment that fosters personal growth, innovation, and continuous improvement.. Join CEVA Logistics, and you will be part of a team that values imagination and continued learning and is committed to excellence in everything we do.. CEVA Logistics is proud to be an equal opportunity work place and an affirmative action employer.. Please note: Legitimate CEVA Logistics recruitment processes include communication with candidates through recognized professional networks, such as LinkedIn or via an official company email address: firstname.lastname@cevalogistics.com.
The ideal candidate will collaborate with HR and business stakeholders to translate workforce planning needs into scalable SAC models, streamline data flows, and ensure effective use of workforce planning capabilities across the enterprise.. Hands-on experience with SAP Analytics Cloud, preferably with SAC for Planning and/or Workforce Planning use cases.. Familiarity with SAP SuccessFactors and integration points with SAC.. Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).. Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
Reports to: VP Product Development. This company is on the cusp of bringing novel technology which will revolutionize drug delivery.. The person hired for this role will be the Lead Engineer, reporting to a VP. As the product is commercialized, this person would potentially build out a department, and expand teams as new indications are approved.. Qualifications BS in Mechanical or Biomedical Engineering and strong background in life science product development.. Understanding of material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.